Effects of Ketosis on Brain Function in Patients With T1DM

NARecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 3, 2020

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Type1diabetes
Interventions
OTHER

Very low carbohydrate diet

"All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement with each meal as needed to promote digestive health, and a daily multi-vitamin, magnesium and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.~The diet composition will be as follows: 5% carbohydrate, 75% fat, 20% protein."

OTHER

Standard carbohydrate diet

"All meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.~The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein."

Trial Locations (1)

02115

RECRUITING

Boston Childrens Hospital, Boston

All Listed Sponsors
collaborator

Beth Israel Deaconess Medical Center

OTHER

lead

Boston Children's Hospital

OTHER